Ongoing Assessments

Alzheimer’s Disease

ICER

Anemia in Chronic Kidney Disease

CTAF

Bladder Cancer

Midwest CEPAC

COVID-19

ICER

Hemophilia A

New England CEPAC

High Cholesterol

Midwest CEPAC

Lupus Nephritis

New England CEPAC

Multiple Myeloma

Midwest CEPAC

Opioids: Digital Therapeutics

Midwest CEPAC

Opioids: Supervised Injection Facilities

New England CEPAC

PTSD: Service Dogs

ICER

Sickle Cell Disease

New England CEPAC

Unsupported Price Increase Assessment

ICER

past Topics

2020 Value Assessment Framework

Jan 2020
ICER

In January 2020, ICER will issue an update to the framework that underpins our evidence reports on new drugs and other health care interventions. ICER’s value framework is the product of more than 10 years’ experience working with all participants in the health care system to develop methods to assess the comparative clinical effectiveness and the comparative value of health care tests, treatments, and delivery system innovations. The current iteration of the framework has guided ICER’s assessments from 2017 to 2019.

To inform the planned update, ICER will open a national call for suggestions on how to improve our value assessment framework. Based on the feedback we receive, we plan to publish draft revisions to our value assessment framework on August 21st, welcome public comment on those proposed revisions through October 18th, and post our final updated framework on January 31st. This final framework will be applied to all assessments initiated in 2020 and beyond.

For questions, please contact info@icer-review.org.

ICER’s Value Framework and Patient Feedback: Q&A with Steve Pearson (Webinar Recording | Webinar Q&A Responses )

September 4, 2019

ICER conducted a fireside chat moderated by Tanisha Carino, ICER Board member and Executive Director of FasterCures, with Steve Pearson, ICER’s Founder and President. This hour-long conversation explored the mission of ICER, with an emphasis on ICER’s Value Assessment Framework revisions. Hear about the suggestions ICER received as part of its recent public comment period, proposed changes, and how you and your organization can continue to be part of improving our process. This webinar was intended for patient organizations and was open to the public.

ICER is also working on the “Valuing a Cure” initiative:

ICER is simultaneously developing methods adaptations to its value framework to be applied in the assessment of potential cures and other treatments that qualify as “single or short-term transformative therapies,” or SSTs. While these proposals do not fundamentally alter ICER’s approach to value assessment, they are intended to equip decision makers with a more reliable and transparent evaluation of SSTs’ uncertainty, value, and value-based pricing. Please see the site on cures here.

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Abuse-Deterrent Opioids

Jul 2017
New England CEPAC

Opioids are used to treat cases of acute and chronic pain that arise from a variety of causes, ranging from trauma to palliative care for advanced illness. Every year, 100 million people in the United States suffer from pain, 9-12 million of whom have chronic or persistent pain. Although opioid therapy is an important component of pain management for many patients, the addictive and euphoric properties of these drugs make them liable to misuse, abuse, addiction, and diversion.

In an effort to help tackle the public health crisis of opioid dependence, misuse, and addiction that has emerged over the last decade, drug manufacturers have begun to develop abuse-deterrent formulations of opioid medications (ADFs). ICER will review available evidence on the comparative clinical effectiveness and comparative value of ADFs in order to inform decision-making by patients, clinicians and policy-makers, within the context of multiple efforts being undertaken to combat the opioid crisis. ICER’s review will also analyze the potential of ADFs to reduce the burden of prescription opioid abuse by evaluating their benefits and market penetration based on coverage policies and legislation.

Interventions of Interest:

  • Hysingla® ER (Hydrocodone, Purdue)
  • Vantrela® (Hydrocodone , Teva)
  • Arymo® ER ( Morphine, Egalet)
  • Embeda® (Morphine + naltrexone, Pfizer)
  • MorphabondTM (Morphine extended release, Inspirion Delivery Technologies)
  • OxyContin® TR (Oxycodone, Purdue)
  • Xtampza®ER (Oxycodone, Collegium Pharmaceutical Inc)
  • Targiniq® (Oxycodone + naloxone extended release, Purdue)
  • Troxyca® ER (Oxycodone + naltrexone, Pfizer)
  • RoxyBond® (Oxycodone, Inspirion Delivery Technologies)

Date of Review: July 2017

 

For questions or additional information, please contact info@icer-review.org

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Acute Migraine

Jan 2020
Midwest CEPAC

ICER will assess the comparative clinical effectiveness and value of treatments for acute migraine, including:

  • Two oral CGRP receptor antagonists, rimegepant (Biohaven) and ubrogepant (Allergan)
  • A 5-HT1f agonist lasmiditan (Eli Lilly).

All three of these agents are under FDA review with an anticipated decision in the final quarter of 2019.

Date of review: January 2020

For questions, please contact info@icer-review.org.

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Amyloidosis

Oct 2018
Midwest CEPAC

ICER reviewed new therapies for the treatment of hereditary transthyretin-related (hATTR) amyloidosis, a rare genetic condition characterized by nerve, heart, and eye damage that is currently treated through supportive measures alone. Therapies included inotersen (Akcea Therapeutics ), an antisense oligonucleotide that interferes with transthyretin production in the liver, and patisiran (OnpattroTM, Alnylam Pharmaceuticals), which inhibits transthyretin through an RNA interference pathway.

 

For questions or additional information, please contact info@icer-review.org

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Arthritis

Oct 2017
CTAF, New England CEPAC

Rheumatoid arthritis (RA) is the most common autoimmune inflammatory arthritis in adults, affecting approximately 1.5 million Americans. RA is more common in women and may occur at any age, with peak incidence occurring at ages 50-60 years. RA is typically characterized by morning stiffness and symmetrical joint swelling of the feet, hands, and knees, although any joint (and in some cases, internal organs) may be involved. The course of RA may be complicated by cardiac, hematologic, and other extra-articular manifestations.

2019 Review* – Interventions of Interest:

JAK- Inhibitors

  • Baricitinib (Olumiant®, Eli Lilly and Co.)
  • Tofacitinib (Xeljanz®, Pfizer)
  • Upadacitinib (AbbVie) – currently under FDA review

In addition to this list of drugs, ICER is considering investigating several biosimilars as part of the 2019 review.

*In June 2019, ICER refocused the review on JAK inhibitors only, as opposed to a full class review.

2017 Interventions of Interest:

TNF Inhibitors

  • Adalimumab (Humira®, Abbvie)
  • Certolizumab pegol (Cimzia®, UCB)
  • Etanercept (Enbrel®, Amgen)
  • Golimumab (Simponi®, Janssen)
  • Infliximab (Remicade®, Janssen)

CD20- Directed Cytolytic Antibody

  • Rituximab (Rituxan®, Genentech)

T Cell Inhibitor

  • Abatacept (Orencia®, BMS)

IL-6 Inhibitors

  • Sarilumab (Kevzara®, Sanofi and Regeneron Pharmaceuticals)
  • Tocilizumab (Actemra®, Genentech)

JAK- Inhibitors

  • Tofacitinib (Xeljanz®, Pfizer)
  • Baricitinib (Eli Lilly and Co.)

For questions, please contact info@icer-review.org.

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Asthma

Nov 2018
CTAF, Midwest CEPAC

An estimated 22 million Americans have asthma, which causes the airways of the lungs to narrow or become blocked, making it hard to breathe. Among both young and old, asthma can have a significant impact on health and limit the ability to pursue many activities.

Interventions of Interest, 2018 review: Dupilumab (Dupixent®, Sanofi/Regeneron), omalizumab (Xolair®, Genentech/Novartis), mepolizumab (Nucala®, GlaxoSmithKline), reslizumab (Cinqair®, Teva), and benralizumab (Fasenra, AstraZeneca)

Intervention of interest, 2016 review: Mepolizumab (Nucala®, GlaxoSmithKline plc.

 

For questions or additional information, please contact info@icer-review.org

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Atherosclerotic Cardiovascular Disease

Nov 2018
CTAF

In June 2018, ICER announced its intention to assess the comparative clinical effectiveness and value of canakinumab (Novartis) for cardiovascular risk reduction in people with atherosclerosis. However, in October 2018, when the Food and Drug Administration declined to approve canakinumab’s expanded indication for atherosclerotic cardiovascular disease, ICER announced it would no longer proceed with its value assessment.

 

For questions or additional information, please contact info@icer-review.org

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Atopic Dermatitis

May 2017
Midwest CEPAC

Atopic dermatitis (eczema) is a chronic/chronically-relapsing skin condition characterized by itching and dry skin. Atopic dermatitis is common. It affects 5-20% of children worldwide, and approximately 11% of children in the US. It is also estimated to affect around 3-7% of adults in the US. Management of atopic dermatitis can create burdens for the family, and the disorder can decrease quality of life. Itching, in particular, can disrupt sleep and lead to daytime sleepiness, irritability, and psychological stress, and cosmetically important lesions can lead to social stress and isolation.

ICER’s report will evaluate the comparative clinical effectiveness and value of two emerging therapies for atopic dermatitis: crisaborole and dupilumab. Crisaborole will be evaluated based on its expected indication in the treatment of mild-to-moderate atopic dermatitis in children and adults; separately, dupilumab will be evaluated for its expected indication in the treatment of moderate-to-severe atopic dermatitis in adults.

Interventions of Interest:

  • Crisaborole (Eucrisa™, Pfizer, Inc.)
  • Dupilumab (Dupixent®, Sanofi and Regeneron, Inc.)

Date of Review: May 2017

 

For questions or additional information, please contact info@icer-review.org

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Atrial Fibrillation

Jun 2011
ICER, New England CEPAC

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the US population. AF occurs when rapid, disorganized electrical signals cause the atria (the two upper chambers of the heart) to “fibrillate”, or contract quickly and irregularly. This in turn causes some blood to pool in the atria rather than be pumped completely into the ventricles. AF can be asymptomatic but it may also be associated with several bothersome symptoms, including shortness of breath, difficulty with exercise, palpitations, general fatigue, dizziness, and confusion.

Interventions of interest:

Antiarrhythmic drugs (amiodarone, dronedarone)
Catheter ablation
Surgical ablation

Date of review: June 2011


Interventions of interest:

Antiarrhythmic drug therapy to return the heart to sinus rhythm
Radiofrequency catheter ablation to terminate AF and prevent further episodes
Minimally-invasive surgical techniques to terminate AF and prevent further episodes
Aspirin, warfarin, and dabigatran for anticoagulation to prevent strokes
The WATCHMAN left atrial appendage occlusive device to prevent strokes

Date of review: September 2010

 

For questions or additional information, please contact info@icer-review.org

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Attention Deficit Hyperactivity Disorder

Jun 2012
New England CEPAC

Diagnoses of Attention Deficit Hyperactivity Disorder (ADHD) have risen in recent years, and ADHD is now regarded to be a common condition among children in the United States. While reported prevalence ranges widely between 6-16% depending on location and measurement technique, it has been estimated that ADHD affects at least 5 million children aged 4-17 years in the U.S. Given the substantial burden of ADHD for children and their families, as well as the significant longterm implications that a diagnosis of ADHD carries, there is significant interest on the part of patients, clinicians, policymakers, and other stakeholders in exploring different management options for ADHD.

Interventions of interest:

Parent behavior training
School-based interventions
Stimulants
Non-stimulants

Date of review: June 2012

 

For questions or additional information, please contact info@icer-review.org

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